Effectiveness of Intensive Rehabilitation on Shoulder Function After Proximal Humerus Fracture

Effectiveness of Intensive Rehabilitation on Shoulder Function After a Fracture of the Proximal Humerus Treated by Locked Plate. A Prospective Randomized Study

The fracture of the proximal humerus represents 4% of the fractures encountered in clinics and it must be treated surgically. Thus, the aim of the surgical treatment is to maintain bone alignment, articular congruity, vascularization of the humeral head and provide a painless shoulder with satisfactory function.

The objective of this study is to demonstrate the potential benefits of an early rehabilitation program on shoulder function.

Study Overview

• Status: Unknown
• Conditions: Fracture of Proximal Humerus
• Intervention / Treatment: Device: PHILOS™ locked plate system by Synthes Canada©; Other: Early and intensive exercise program; Other: Standard rehabilitation program

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hélène Côté, Reg. Nurse; Phone Number: 3165 1-418-649-0252; Email: helco3@hotmail.com

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1J 1Z4
      • Recruiting
      • CHA-Pavillon Enfant-Jésus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female over 18 years
• Unstable fracture of the proximal humerus
• Two-part and three-part fractures according to the Neer classification
• Closed fracture
• Time between trauma and surgery less than or equal to 7 days
• Signing of consent form

Exclusion Criteria:

• Stable fracture of the proximal humerus (not requiring surgery)
• Four-part fracture on the Neer classification
• Fracture-dislocation or fracture involving the articular surface
• Isolated fracture of the large or small tuberosity
• Pathological fracture
• Fracture associated with neuro-vascular lesions
• Bilateral fractures
• Fracture associated with long bones fracture
• Polytrauma
• Previous history of fracture or surgery to the ipsilateral proximal humerus
• Severe COPD
• Severe neuromuscular disorders (Parkinson, hemiparesis, myasthenia gravis, muscular dystrophy, etc. ...)
• Remote location of patient's home which makes it difficult to come to facility for follow-up visits
• Any medical condition making it impossible for the patient to perform the exercise program (Alzheimer, dementia, etc. ...)
• Man or woman incapacitated sign consent form
• Any other condition which prevents the assessor from fully monitoring the patient during study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Intensive Rehabilitation	Device: PHILOS™ locked plate system by Synthes Canada©; The surgery will be performed under standardized general anesthetic with a prophylactic antibiotic. The deltopectoral approach is used in all cases. The fracture will be fixed using the PHILOS locked plate system by Synthes Canada ©. Some additional osteosutures may be used. The wound is irrigated and then closed in two layers at the end of intervention. A splint thoracic brace will be installed in all patients before the end of anesthesia.; Other: Early and intensive exercise program; A thoraco brachial brace will be worn for 48 hours following the surgery and then removed for the remainder of treatment. Patients will then start the intensive rehabilitation program without physical therapy. The exercise program will be provided to the patient. The exercises consist of active and active assisted movements of the shoulder for a period of six weeks, limiting external rotation to 0 °. Patients are encouraged to use their affected limb for daily activities. Strengthening exercises are started the 6th week following surgery and the full program will be completed three months after surgery. Patients who wish can then continue their rehabilitation with a physiotherapist. The patient will complete a daily diary to validate the frequency and intensity of the exercises.
ACTIVE_COMPARATOR: Standard Rehabilitation	Device: PHILOS™ locked plate system by Synthes Canada©; The surgery will be performed under standardized general anesthetic with a prophylactic antibiotic. The deltopectoral approach is used in all cases. The fracture will be fixed using the PHILOS locked plate system by Synthes Canada ©. Some additional osteosutures may be used. The wound is irrigated and then closed in two layers at the end of intervention. A splint thoracic brace will be installed in all patients before the end of anesthesia.; Other: Standard rehabilitation program; The patient will wear the thoraco brachial brace for a period of four weeks following the surgery. It may be taken off for hygiene purposes and dressing up. After the four weeks, the patient will take the brace off permanently and begins an exercise program, writing down the frequency and intensity of the exercises. Physiotherapy is allowed for the remaining part of the three months rehabilitation program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome on Constant score	The investigators will validate that early and intensive rehabilitation gives a better functional outcome at 6 months using the Constant score adjusted for age. A difference of 10 points is considered significant (standard deviation of 15 points).	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of reoperation	The rate of complications such as infection, implant removal, implant failure and necrosis which necessitate additional surgery.	within the first year following surgery
Loss of radiological reduction	The main displacements occur in varus and it will be measured on a radiography on an AP view of Neer. The neck-shaft angle will be measured and a difference of 10 degrees will be considered significant to account for the lack of standardization of the radiological technique.	1 or 2 days after surgery
Loss of radiological reduction	The main displacements occur in varus and it will be measured on a radiography on an AP view of Neer. The neck-shaft angle will be measured and a difference of 10 degrees will be considered significant to account for the lack of standardization of the radiological technique	10-14 days after surgery
Loss of radiological reduction	The main displacements occur in varus and it will be measured on a radiography on an AP view of Neer. The neck-shaft angle will be measured and a difference of 10 degrees will be considered significant to account for the lack of standardization of the radiological technique	3 or 4 months after surgery
Loss of radiological reduction	The main displacements occur in varus and it will be measured on a radiography on an AP view of Neer. The neck-shaft angle will be measured and a difference of 10 degrees will be considered significant to account for the lack of standardization of the radiological technique	6 months after surgery
Loss of radiological reduction	The main displacements occur in varus and it will be measured on a radiography on an AP view of Neer. The neck-shaft angle will be measured and a difference of 10 degrees will be considered significant to account for the lack of standardization of the radiological technique	12 months after surgery
Sustainability of the efficacy on Constant score	Constant score will be measured one year after surgery to demonstrate the sustainability of the efficacy of intensive rehabilitation.	12 months after surgery
Quality of life on DASH scale	The quality of life is measured using the DASH scale 3 months after surgery.	3 months after surgery
Quality of life on DASH scale	Quality of life is measured using the DASH scale 6 months after surgery.	6 months after surgery
Quality of life on DASH scale	Quality of life is measured using the DASH scale 12 months after surgery.	12 months after surgery
Return to professional activities	This will be determined in days after surgery, to rates of 50% and 100% of the usual workload.	3 or 4 months after surgery
Pain on visual analog scale (VAS)	The measure will be carried out using a suitable rule designed for this type of measurement, counting only full numbers from 1 to 10 on VAS.	10-14 days after surgery
Pain on VAS	The measure will be carried out using a suitable rule designed for this type of measurement, counting only full numbers from 1 to 10 on VAS.	3 or 4 months after surgery
Pain on VAS	The measure will be carried out using a suitable rule designed for this type of measurement, counting only full numbers from 1 to 10 on VAS.	6 months after surgery
Pain on VAS	The measure will be carried out using a suitable rule designed for this type of measurement, counting only full numbers from 1 to 10 on VAS.	12 months after surgery
Measurement of range of motion of shoulder	Using a goniometer, we will measure the bending (normal value 180 °), abduction (180 °), external rotation in the scapular plane (90 °) and internal rotation in the plane scapula (60 °).	3 months after surgery
Measurement of range of motion of shoulder	Using a goniometer, we will measure the bending (normal value 180 °), abduction (180 °), external rotation in the scapular plane (90 °) and internal rotation in the plane scapula (60 °).	6 months after surgery
Measurement of range of motion of shoulder	Using a goniometer, we will measure the bending (normal value 180 °), abduction (180 °), external rotation in the scapular plane (90 °) and internal rotation in the plane scapula (60 °).	12 months after surgery

Collaborators and Investigators

• Sponsor: Hopital de l'Enfant-Jesus
• Investigators: Principal Investigator: Annie Arteau, MD, Hôpital Enfant-Jésus

Publications and helpful links

General Publications

• Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ANTICIPATED): December 1, 2013
• Study Completion (ANTICIPATED): December 1, 2013

Study Registration Dates

• First Submitted: April 28, 2010
• First Submitted That Met QC Criteria: April 28, 2010
• First Posted (ESTIMATE): April 29, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): December 20, 2012
• Last Update Submitted That Met QC Criteria: December 19, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: humerus fracture; locked plate
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: PEJ-525